Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Glaucoma Clinical Trial

Official title:

An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With Benzalkonium Chloride (AT-BAK) on the Response to the Latanoprost Punctal Plug Delivery System (L PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845299
• Other study ID #: PPL GLAU 04
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2009
• Last updated: September 16, 2013
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2013
• Source: Mati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years with ocular hypertension or open-angle glaucoma

• Subjects who have a best-corrected visual acuity of 20/100 or better

Exclusion Criteria:

• Subjects who wear contact lenses

• Uncontrolled medical conditions

• Subjects with a known sensitivity to latanoprost, BAK, or any other products required for the study

• Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Latanoprost punctal plug
Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.
• artificial tears preserved with Benzalkonium Chloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP change from baseline		6 weeks	No